- Full Time
Website GSK Pharma
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About GSK Pharma
GSK Pharma a global biopharmaceutical company, has a unique mission: to bring together science, technology, and talent to proactively combat disease collectively. This approach aims to have a positive impact on the health of billions of people while ensuring sustainable shareholder returns and creating an environment where individuals can flourish. Going beyond just treating diseases, GSK is committed to preventing them as well. The company’s ambitious goal is to improve the health of 2.5 billion individuals worldwide within the next decade.
Job Post: Regulatory Specialist – Submissions Assembly
The Regulatory Submission Assembly – Level 1 role involves coordinating with multiple stakeholders/LOC to obtain regulatory submission documents for the preparation of a quality dossier within an agreed timeline. The primary responsibility is to facilitate submissions to respective agencies with high quality, supporting Global Regulatory with minimal input from the line manager.
Key Responsibilities at GSK Pharma:
- Understanding regulations, guidelines, and developing procedures/policies related to pharmaceutical product registration and manufacturing.
- Drive the submission and delivery process with the Global Publishing team to ensure timely dispatch and archival of submissions as per agreed timelines.
- Delivery of submission packages to an agreed schedule and technical specification.
- Advise and assist authors in the preparation of submission content and use of GSK document management systems and procedures.
- Collaborate across functions, working with stakeholders in development functions for advice interpretation, researching topics, and issue resolution.
Candidate Profile at GSK Pharma:
- 0-6 years of experience in Regulatory Affairs or related responsibilities.
- Excellent organizational skills, attention to detail, and commitment to delivering high-quality output under pressure.
- Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes and objectives.
- Excellent written and verbal communication skills, with the ability to present information clearly and concisely.
- Ability to build effective working relationships and work efficiently in a matrix environment.
- Proficient in computer applications (MS Word, MS Excel, Adobe PDF, SharePoint, Internet Explorer) and preferably experienced with complex IT tools in a large organization.
- Ability to think flexibly to meet constantly shifting priorities and timelines.
Other Job-Related Skills/Background:
- Effective communication in English.
- Strong sense of urgency, able to prioritize effectively for timely handling of key issues.
- Service-oriented attitude with the ability to interact effectively with personnel at all levels in an interdisciplinary and matrix environment.
- Highly developed interpersonal, presentation, and communication skills with established internal and external networks.
- Experience Required at GSK Pharma: 0-6 years of experience
- Location: Bengaluru
- Req ID: 384715
- Industry Type: Pharma / Healthcare / Clinical research
- End Date: 30th December 2023
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